Actively Recruiting
A Phase II Study of Loncastuximab Tesirine as Consolidation Strategy in Patients With LBCL in PR After CAR T-cell Therapy
Led by M.D. Anderson Cancer Center · Updated on 2026-01-12
30
Participants Needed
1
Research Sites
383 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To learn if loncastuximab tesirine (called "lonca" in this informed consent form) can help to control large B-cell lymphoma that is relapsed or refractory after receiving CAR T-cell therapy. The safety and possible effects of the study therapy will also be studied.
CONDITIONS
Official Title
A Phase II Study of Loncastuximab Tesirine as Consolidation Strategy in Patients With LBCL in PR After CAR T-cell Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of relapsed or refractory diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, transformed indolent B-cell lymphomas, or high-grade B-cell lymphoma
- Received FDA-approved anti-CD19 autologous CAR T-cell therapy outside a clinical trial
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Achieved partial response according to Lugano 2014 criteria 30 days after CAR T-cell therapy
- At least 30 days have passed since CAR T-cell therapy infusion
- No evidence of CD19 expression after CAR T-cell therapy
- No additional anti-tumor therapy received after CAR T-cell therapy except palliative radiotherapy
- Absolute neutrophil count (ANC) of at least 1.0 x10^9/L without growth factor support for 3 days before screening
- Platelet count of at least 50 x10^9/L without transfusion for 3 days before screening
- Creatinine clearance of at least 30 mL/min
- Serum ALT or AST less than or equal to 2.5 times the upper limit of normal
- Total bilirubin less than or equal to 2 mg/dL, except in Gilbert's syndrome
- Cardiac ejection fraction of at least 45% with no significant pericardial effusion
- Baseline oxygen saturation over 92% on room air
- No evidence or suspicion of lymphoma involving the central nervous system
- Females of childbearing potential have a negative pregnancy test
- Resolution of any previous cytokine release syndrome and/or immune effector cell-associated neurotoxicity syndrome to grade 0
You will not qualify if you...
- Significant third space fluid accumulation requiring drainage or causing breathing difficulty
- History of other malignancies unless disease-free for at least 12 months (except nonmelanoma skin cancer or carcinoma in situ)
- History of Richter's transformation of chronic lymphocytic leukemia
- Treatment with CAR T-cell therapy on a clinical trial immediately before enrollment
- Prior treatment with loncastuximab tesirine
- Uncontrolled fungal, bacterial, viral, or other infections requiring intravenous antimicrobials
- Known infection with HIV, hepatitis B, or hepatitis C unless viral load is undetectable
- Active cardiac lymphoma involvement
- History of significant cardiac events within 12 months before enrollment
- Primary immunodeficiency
- Autoimmune diseases causing organ injury or requiring systemic immunosuppression within 2 years
- Recent deep vein thrombosis or pulmonary embolism within 1 month
- Medical conditions interfering with safety or efficacy assessment
- History of severe immediate allergic reactions to study agents
- Pregnant or breastfeeding women of childbearing potential
- Subjects unwilling to use effective birth control as required
- Inability or unwillingness to comply with study visits or procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
P
Paolo Strati, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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